ceremony of research project

Instructions for Submission

Full Committee Review

Submit 11 copies of the application, consent form, and other supporting documents such as surveys, questionnaires, etc. Staple or clip the copies as individual sets in the following order: application, consent form, supporting documents. If you have questions, please call our office (Joy Toavs 406-768-5555).

Expedited Review

Submit 3 copies of the application, consent form, and other supporting documents such as surveys, questionnaires, etc. Staple or clip the copies as individual sets in the following order: application, consent form, supporting documents. If you have questions, please call our office (Joy Toavs 406-768-5555).

Request For Exemption

If a protocol falls under the "Exempt" category, that does NOT mean that you do not need to submit an application. It means that it is exempt from full committee review and follow up reviews as long as there are no changes to the protocol. Any changes to an approved protocol need to be reviewed and approved by the IRB Chair. Submit one (1) copy of the Request for Exemption Application Consent Form, and other supporting documents such as surveys, questionnaires, etc. See "Required Wording" for surveys and questionnaires. Staple or clip the documents as a set in the following order: application, consent form, supporting documents. If you have questions, please call our office (Joy Toavs 406-768-5555).

Request For Minor Modifications

Requests for minor modifications can be made by sending an e-mail to: (Joy Toavs 406-768-5555). Provide the title of the protocol and the approval number for the protocol you wish to modify. List all modifications you want to make. If the consent form is being modified, we need a copy of the revised consent form.

Renewals

NOTE: The IRB and investigators must plan ahead to meet required continuing review dates. If an investigator has failed to provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, the research must stop. Enrollment of new subjects cannot occur after the expiration of IRB approval.

The IRB Office will send out renewal forms approximately one (1) month prior to the renewal date. The approval number assigned to the protocol is indicated in brackets after the title of the protocol. The approval number is usually two letters (PI's initials) followed by six numbers, which is the date the protocol was approved. So, if John Doe's protocol was approved on October 24, 2008, his assigned approval number would be JD102408. This way you know when your renewals are due. If you know that your protocol is nearing the expiration date and you have not received the renewal forms from our office, please contact our office as soon as possible so that your approval does not lapse. It is ultimately the responsibility of the PI to maintain compliance with these regulations. There is a 30-day window in which protocols can be renewed (not more than 30 days prior to renewal date and absolutely not after the renewal date). If the Fort Peck IRB’s regularly scheduled meeting does not fall within the 30-day renewal window, the IRB Administrator will schedule a special meeting time for the purpose of reviewing the renewal request.

The guidance document for renewals is found at: http://www.hhs.gov/ohrp/policy/continuingreview2010.html

Questions and Comments: irb@fpcc.edu (406-768-5555).